drugset
drugset / Trial / NCT02408523

A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications

NCT02408523 ↗

Phase 3 Completed 242 enrolled UCB BIOSCIENCES, Inc. Pharmaceutical Research Associates · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.

Timeline

Start
2015-04
Primary completion
2019-04
Completion
2019-06

Outcome

Met primary endpoint

registry p <0.001; Hazard Ratio (HR) 0.540 (95% CI 0.377 to 0.774) NCT02408523 ↗

registry A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo. NCT02408523 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lacosamide Other / unclassified 8 mg/kg Oral
Subject Lacosamide Other / unclassified 12 mg/kg Oral
Subject Lacosamide Other / unclassified 400 mg Oral

Indications

epilepsy